CORIMUNO-19 - Tocilizumab Trial - TOCI (CORIMUNO-TOCI)

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The overall objective of the study is to determine the therapeutic effect and tolerance of Tocizilumab in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus disease 2019 (COVID-19). Tocilizumab (TCZ) is an anti-human IL-6 receptor monoclonal antibody that inhibits signal transduction by binding sIL-6R and mIL-6R. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering Tocilizumab administration to patients enrolled in the COVIMUNO-19 cohort. Tocilizumab will be administered to consenting adult patients hospitalized with CORVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation. Patients who will chose not to receive Tocilizumab will receive standard of cares. Outcomes of Tocilizumab-treated patients will be compared with outcomes of standard of care treated patients as well as outcomes of patients treated with other immune modulators.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Criteria

Inclusion Criteria:

1. Patients included in the CORIMUNO-19 cohort

2. Patients belonging to one of the 2 following groups:

• Group 1: Cases meeting all of the following criteria

• Requiring more than 3L/min of oxygen

• OMS/WHO progression scale = 5

• No NIV or High flow

• Group 2: Cases meeting all of the following criteria

• Respiratory failure AND (requiring mechanical ventilation OR NIV OR High flow)

• WHO progression scale >=6

• No do-not-resuscitate order (DNR order)

Exclusion Criteria:

• Patients with exclusion criteria to the CORIMUNO-19 cohort.

• Known hypersensitivity to Tocilizumab or to any of their excipients.

• Pregnancy

• Current documented bacterial infection

• Patient with any of following laboratory results out of the ranges detailed below at screening should be discussed depending of the medication:

• Absolute neutrophil count (ANC) ≤ 1.0 x 109/L

• Haemoglobin level: no limitation

• Platelets (PLT) < 50 G /L

• SGOT or SGPT > 5N